By Curtis L. Harrington
A recent case in the medical field examines the necessity to mark devices associated with a patent.
In a patent infringement suit, damages recoverable from an infringer begin to accrue after an infringer has notice of the existence of a patent covering the infringer's activities. Of course, one type of notice which will always meet this requirement is actual notice which is had by communicating directly with the infringer. Unless the patented item is specific to a narrow and definable group of potential infringers, the burden involved in giving direct notice is significant. However, notice may be presumed where the patentee, or his licensees properly mark the articles produced which are covered by the patent. When patented articles are properly marked, the presumed notice enables the patentee to collect money damages from acts which occur prior to giving actual, direct notice to the patent infringer.
The specifics on marking were set forth in the recent case American Medical Systems Inc. v. Medical Engineering Corp. (CAFC 1993) 28 USPQ2d 1321, which involved a patent relating to a prosthesis.
The parties to this case were vigorous competitors in the area of penile prostheses. American Medical Systems Patent No. 4,597,765 was directed to a method and apparatus for packaging a fluid-containing penile prosthesis in a pre-filled, sterile state.
The subject matter of the patent solved the problems of prior art packaging by pre-filling the prosthesis with a saline solution and immersing it in a foil pouch filled with a saline solution having the same osmotic properties. This allowed the liquid level within the device to be maintained precisely while in storage and prior to implementation.
Prior to issuance of the patent on July 1, 1986, 8,556 unmarked prostheses were shipped. Products were not marked until two months after issuance of the patent, and such marked products did not begin shipment until October 15, 1986; some 32 months later. The district court concluded that American Medical Systems was "obligated to have marked all [products] subsequent to the issue [issuance] of the patent except that it is allowed a relatively small number to be shipped unmarked as it readies the marking process." Because it had shipped more than a de minimis number of products after the patent issued without the requisite marking, it failed to comply with the mechanism set forth in 287(a).
This mechanism comes from 35 U.S.C. 287(a) which provides that "Patentees and persons making or selling any patented article for or under them, may give notice to the public that the same is patented, either by fixing thereon the word "patent" or the abbreviation "pat.", together with the number of the patent, or when from the character of the article, this cannot be done, by fixing to it, or to the package wherein one or more is contained, a label containing a like notice. In the event of failure so to mark, no damages shall be recovered by the patentee in any action for infringement, except on proof that the infringer was notified of the infringement and continued to infringe thereafter, in which event damages may be recovered for the infringement occurring after such notice."
In general, once a valid patent has issued, and once the infringer's activities have commenced, damages will be allowed at the earlier of (1) the date the infringer received actual notice, or (2) where notice can be imputed by marking the patentee's products. This case also indicates that such marking must begin soon after the patent issues, and if not, actual notice must occur.
In the present case, marked product was shipped on October 15, 1986. In the present case, the defendant in the lawsuit did not receive actual notice until October 28, 1987. More than a year's worth of damages was lost.
An exception to this marking rule applies where the infringed claims are exclusively method claims. Method claims are those claims which recite the performance of a process, such as process for preparing a chemical compound, for example. Device or apparatus claims, on the other hand, are typically descriptive of a structure relating to a machine or useful article. Thus, in the case where only method claims of a patent are infringed, there is no notice limitation on the collection of money damages for infringement, meaning that no notice need be given during the time in which damages begin to accrue.
Beware however, the situation where a product infringes both the method and device claims of a patent. Where there are both product and method claims which are infringed, the patentee must mark the products, and 35 U.S.C. 287(a) does apply.
The rational for the above rules lies in the purpose to encourage the patentee to give notice to the public of his patent. In the case where the only claims infringed are method claims, there is nothing which exists which can be marked. Where the patent contains claims relating both to method and apparatus, such that marking can occur, the patentee will be obliged to mark those articles which can be marked.
In addition to the motivation provided by the above damages provision, marking an article with a patent number reduces the amount of research and time expended by potential licensees in contacting the patentee since the name and address of the patentee will appear on the face of the patent. If an assignment was executed before the patent issued, the name and address of the assignee, if any, will appear on the face of the patent. At the very least, the marking of articles with a patent number provides a direct marketing line to the patentee, regardless of the many labeling and distribution channels through which the product may pass before it becomes available to the public.
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